K-number	K252959
Device name	WRISTAR MultiAx Distal Radius Kit
Applicant	Intrauma S.P.A
Product code	HRS
Device class	Class II
Decision date	Nov 12, 2025
Decision	Substantially Equivalent
Regulation	888.3030

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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WRISTAR MultiAx Distal Radius Kit

Everything you need for a 510(k) submission. Nothing you don't.